Comparison of IPX066 with carbidopa-levodopa plus entacapone in advanced PD patients

20th October 2014 - New research

CLINICAL TRIAL RESULTS OF DUAL LAYER L-DOPA

Dual layer L-dopa (IPX066), which is being developed for the treatment of Parkinson's Disease, unusually and advantageously combines the immediate release version of L-dopa with the controlled release version of L-dopa. An application by Impax is with the FDA for the marketing of IPX066 as Rytary.

For more information go to : http://www.drugs.com/nda/rytary_140411.html Rytary

The effect of Dual Layer L-dopa on Parkinson's Disease was compared to the effect of sinemet plus Entacapone, which is one of the most effective forms of L-dopa.

IPX066 demonstrated improved efficacy. The average dosage of L-dopa used in IPX066, after accounting for availability, was 22% higher than in Sinemet and Entacapone.

IPX066 demonstrated less "off" time (3.8 hours instead of 5.2 hours per day). IPX066

demonstrated higher "on" time without dyskinesia (11.4 hours instead of 10 hours per day).

Other measures favoured IPX066. There were more adverse events when taking IPX066. The most common adverse events were dyskinesia, insomnia, and confusional state for IPX066, and falling for Sinemet and Entacapone.

Reference : Parkinsonism Related Disorders [2014] Aug 15 [Epub ahead of print] (F.Stocchi,

A.Hsu, S.Khanna, A.Ellenbogen, A.Mahler, G.Liang, U.Dillmann, R.Rubens, S.Kell, S.

Gupta) Complete abstract : http://www.ncbi.nlm.nih.gov/pubmed/25306200